The present invention generally relates to antimicrobial pre-operative skin-preparation delivery systems and more specifically, the present invention relates to antimicrobial, such as povidone iodine (PVP-I), alcohol pre-operative antimicrobial skin-prepataions in a gel form and delivery devices for the skin-preparations.
Standard surgical procedures require the surgical site to be disinfected prior to surgery. Effective pre-operative cleansing of the surgical site is critical to reducing the risk of infection to the patient. Pre-operative skin preparation is therefore as important as the prophylactic antibiotic treatment in control of infection.
Microorganisms on the skin can be transient or resident. Transient microorganisms lie on the surface of the skin, while resident microorganisms are found at deeper sites in the skin, for example, in skin hair follicles. During pre-operative procedures it is desirable to initially kill the microorganisms relatively quickly to reduce the length of time to prepare the patient for surgery. It is also important that the antimicrobial activity can be sustained throughout the surgical procedure by the skin-preparation.
Iodophore has been widely used as a disinfectant and as a pre-operative skin preparation. Pre-operative skin-preparation liquid solutions such as PVP-I scrub and paint solutions are commonly used to disinfect the surgical site prior to surgery. Liquid pre-operative skin-preparations have been stored in liquid containers and dispensed from the liquid containers for application to the surgical site. Existing iodophore skin-preparation solutions typically include iodine, surfactant and a buffer system to provide appropriate pH in an aqueous system. The solutions typically contain an active ingredient of 7.5% to 10.0% povidone iodine. These concentrations of iodine are desirable to provide effective and extended killing of microorganisms.
The conventional method of application of a skin-preparation is to pour bottled skin scrub (7.5% PVP-I) onto a tray, dip a dry sponge into the skin-preparation and apply the soaked sponge to the surface of skin. The skin-preparation is applied from the center to the peripheral areas of the skin site with a circular motion for two to five (2-5) minutes. The sponge provides a physical force to spread the skin-preparation evenly and to remove dead skin cells and skin debris to help the delivery of the skin-preparation to the exposed bacteria. The site is then blotted dry and a skin-preparation paint (10% PVP-I) is applied to the site for two (2) minutes. Conventional skin-preparation systems include several parts and are rather cumbersome to handle. An improved skin-preparation delivery system which does not require the conventional multi-step operation and which requires a shorter time of application is highly desirable and will improve the efficiency and reduce waste.
One existing skin-preparation applicator includes a rigid plastic outer bottle and an applicator head having a sponge. A breakable glass ampule is contained within the rigid plastic bottle. The sealed glass ampule contains a liquid skin-preparation prior to use. The applicator is used by fracturing the glass ampule which releases the liquid skin-preparation. The applicator is tilted to point the applicator head downward such that the liquid skin-preparation travels from the fractured glass ampule to the applicator head. Flow control of the liquid skin-preparation is obtained by varying the amount of tilt of the applicator, and also to some degree, the sponge on the head of the applicator controls the liquid flow rate. A filter screen is provided at the applicator head to trap broken glass from the fractured ampule.
Aqueous iodophore skin-preparations tend to run on the patient""s body to areas that don""t require disinfection, for example, between the patient and the operating table, and may accumulate on those undesired areas where the iodine can cause skin irritation in certain patients. Gel has been added to povidone iodine to reduce running of the skin-preparation. It provides a film texture allowing the antimicrobial to localize at the desirable surgical incision site without reducing the thickness of iodine from the site. Typically, the iodine content of the gel form is about 10.0% w/v or the effect of antimicrobial activity would not be prominent. Povidone iodine containing gel has been stored in containers; however, such containers have not been designed for holding and effectively delivering the povidone iodine gel to a surgical site. In addition, it is desirable if the applicator can be designed such that the skin-preparation flow rate can be controlled to prevent free flow, particularly for liquid skin-preparations.
Although iodine gel provides the advantage as described, it kills microorganisms at a relative slower rate than other antimicrobial agents such as alcohol. Alcohol has long been recognized as a disinfectant which reduces bacteria, fungi, and some viruses at a great speed. However, alcohol alone evaporate quickly. The disinfection action of alcohol does not continue once the alcohol evaporates from the skin. Accordingly, alcohol alone lacks the prolonged ability to disinfect the surgical site.
Various existing containers have been used to store and dispense liquid products, for example, liquid products such as skin-preparation solutions. However, such liquid containers have not been designed for safely storing and effectively delivering antimicrobial alcohol gel skin-preparations. It is desirable to protect pre-operative skin-preparations from contamination while being stored in a container. Also, liquid dispensers typically restrict the flow of the liquid to reduce excessive or uncontrolled dispensing of the liquid. Such liquid dispensers may not adequately protect or provide adequate flow of gels because of the container structure and the different flow characteristics of gels compared to liquids. Furthermore, some existing containers and dispensers have relatively complex constructions which may require numerous components that can result in increased manufacturing costs.
The present invention beneficially provides antimicrobial gel skin-preparation delivery systems which hold and dispense antimicrobial alcohol gel skin-preparations. The delivery systems are capable of being manufactured and shipped with the skin-preparation protectively sealed within a flexible container while providing quick and easy penetration of the seal to open the container for delivery of the skin-preparation.
The present invention by adding alcohol to iodine gel provides further benefits of a rapid and sustained antimicrobial activity, localization of skin preparation by forming a film on the skin, and a single-step of shortened time period application. The invention also provides an opportunity to lower iodine concentration requirement thus reducing the incidence of irritation of certain patients. All these characteristics, in combination, are not described in the precedent skin-preparations or storage and delivery systems.
The present invention provides antimicrobial alcohol gel pre-operative skin-preparation delivery systems for storing and delivering skin-preparations. The skin-preparation delivery systems are easily, efficiently and cost effectively manufacturable and reliably store and deliver antimicrobial alcohol gel formulations. The antimicrobial alcohol gel formulation is protectively sealed within a flexible container until use of the formulation is desired. A gel formulation dispenser is activated to allow delivery of the antimicrobial alcohol gel formulation from the container to a desired site.
The opening to the container is induction sealed with an aluminum foil seal which provides a gas impermeable seal. The gel formulation dispenser has a shoulder hat abuts the sealed edge of the container. The shoulder provides additional integrity nd tightness to the seal between the aluminum foil and the edge of the opening to the container. The gel formulation dispenser has a hollowed spike which can be used to activate the delivery system by sliding the spike toward the seal of the container. The spike can be slid toward the seal by pressing the gel formulation dispenser and the container towards each other. The spike is situated in a non-activated position before use and punctures the aluminum foil seal when placed in activated position which then allows the iodine alcohol gel formulation to flow through the hollowed cavity of the spike. The formulation flows from the hollow spike to an angled sponge head for application to the patient. The angled sponge has openings or holes and is ergonomically designed for skin contact. The ergonomically designed sponge effectively contacts and conforms to contours and folds of the skin. Typically, the sponge is used against the targeted skin area and scrubs the skin from the center to the peripheral areas in a circular movement. The total extractable of the sponge of the dispenser is within the limit of medical devices. The flow rate of the iodine alcohol gel formulation is controlled by the amount of pressure squeezed onto the container by the user""s hand, because the container has flexible walls. The container itself forms a handle of the delivery system and is sufficiently far enough away from the skin to avoid direct touch to the skin by the gloved hand holding the delivery system.
The gel formulation dispenser is connected to the container and has two separate and distinct locked positions, non-activated and activated positions. The formulation dispenser insures that the delivery system is maintained in the non-activated position until activated by a user and also contributes to a single use nature of the system. The skin-preparation delivery system is a single use system because the formulation dispenser cannot be returned to the non-activated position after activation under normal use. Also, the gel formulation dispenser reduces or eliminates accidental opening of the container because the gel formulation dispenser must be manually moved from the non-activated position to the activated position.
The volume of the new skin-preparation delivery system can be easily varied by using different sized containers. Different surgical procedures may require differing amounts of the skin-preparation. By varying the size of the container, the skin-preparation delivery system can be customized for particular surgical procedures. This can reduce waste of skin-preparation use by avoiding oversized delivery systems. Use of multiple delivery systems for a single surgical procedure can also be avoided by customizing the size of the container for the procedure. Accordingly, the present invention can be customized to provide the desired amount of skin-preparation for one or more specific surgical procedures.
Once the skin-preparation delivery system is placed in the activated position, the gel formulation dispenser defines a gel delivery pathway. The gel delivery pathway through the gel formulation dispenser is designed according to the flow characteristics of the antimicrobial alcohol gel formulation such that a desired flow rate of the formulation is achieved. For example, the desired flow rate of the antimicrobial alcohol gel formulation may be a flow rate which quickly and easily delivers the viscous gel formulation from the container to the desired site. Preferably, the antimicrobial alcohol gel formulation is a PVP-I alcohol gel formulation; however, other viscous or non-viscous antimicrobial formulations may be used with the new delivery systems.
The present invention also provides iodine alcohol gel antimicrobial skin-preparations useable to disinfect a surgical site for surgery. The new pre-operative skin-preparation quickly and effectively kills microorganisms when applied to the surgical site. The skin-preparation continues to effectively inhibit microorganism growth in the applied area for a relatively long period of time. Application of the skin-preparation is highly controllable because it does not easily run when applied to a patient. The antimicrobial skin-preparation meets or exceeds the Food and Drug Administration""s proposed performance requirement for pre-operative skin-preparations.
The antimicrobial skin-preparation formula includes iodine, alcohol and gel. The concentration of iodine is relatively low compared to existing skin-preparations. However, the new skin-preparation kills microorganisms quickly upon initial application to the skin and continues to kill microorganisms over an extended period of time. The skin-preparation includes an alcohol at 60.0%-90.0% v/v, an iodophor (iodine) at 1.0%-15.0% w/v, and a gel at 0.1%-20.0% w/v. A preferred antimicrobial skin-preparation includes ethanol at 62.0% v/v, povidone iodine at 5.0% w/v, and gel at 7.5% w/v. Other active and enhancing substances such as surfactants can also be included in the formula.
One advantage of the present invention is that it provides new iodine alcohol gel antimicrobial pre-operative skin-preparation delivery systems which efficiently and effectively store and deliver antimicrobial alcohol gel formulations.
Another advantage of the present invention is to provide skin-preparation delivery systems which can be customized to deliver a desire amount of skin-preparation for a particular surgical procedure.
Another advantage of the present invention is to provide skin-preparation delivery systems which reduce or eliminate contamination of the formulations yet provide quick and easy activation of the system for delivery of the formulations.
Another advantage of the present invention is to provide skin-preparation delivery systems having gel formulation dispensers which are designed for delivery of antimicrobial alcohol gel formulations.
Another advantage of the present invention is to provide povidone iodine alcohol gel antimicrobial pre-operative skin-preparation delivery systems which are easy to use, cost efficient to manufacture, an reliably store and deliver antimicrobial alcohol gel formulations.
Another advantage of the present invention is to provide single use skin-preparation delivery systems.
Another advantage of the present invention is to provide skin-preparation delivery systems which have no glass components.
Another advantage of the present invention is to provide skin-preparation delivery systems which provide improved flow control of the delivery of iodine alcohol gel formulations.
Another advantage of the present invention is to provide skin-preparation delivery systems having a flexible container which contains an iodine alcohol gel formulation.
Another advantage of the present invention is to provide antimicrobial alcohol gel formulations which are easily removed after surgery.
Other objects and advantages of the present invention will become apparent upon reading this disclosure including the appended claims with reference to the accompanying drawings.